Research Ethics: Historical Background
Research Ethics: Historical Background
There is a necessity for the ethical review of scientific research to adequately protect the health, life and dignity of persons involved as subjects in medical researches. This is the central issue discussed by the author in this article.
During the Nazi period, there was a depressing evidence of experiments in which human beings were treated as objects or things or treated with less solicitude than one would treat animals. In the late 1800s, when gonorrhea and syphilis had been the focus of medical-research interest for some years, a Russian doctor documented numerous utterly unethical experiments that were conducted on human beings by eminent and respected physicians in Germany, France, Russia, Ireland, and the United States. Active gonorrheic or syphilitic microorganisms were injected into very sick patients and without their and their family’s consent. It was astonishing that these experiments were not conducted clandestinely but were published in some of the world’s leading medical journal. In 1966, Dr. Henry K. Beecher, a professor at Harvard University Medical School, published two most important components in the ethical approach to research with human subjects. The first was informed consent of the subject patients and second was the presence of an intelligent, informed, conscientious, compassionate, responsible investigator. This publication was a major turning point in the evolution of the ethics of research with human subjects. It was not also the last. However, Dr. Beecher’s ideals were inadequate to fully protect the life, health and dignity of persons involved as subjects in medical research. In 1975, the World Medical Association in its Declaration of Helsinki specified that experimental procedures involving human subjects should be clearly formulated in a research protocol, and should be transmitted to a specially appointed independent committee for consideration, comment and guidance. In the United States, the National Commission for the Protection of Human Subjects for Biomedical and Behavioral Research was created, and who’s Reports and Recommendations on Institutional Review Boards (IRBs) wield considerable power when it comes to experimental procedures involving human subjects. IRBs and research ethics committees (REBs) have the authority to approve, reject or demand modifications of protocols.
Because the published guiding principles for research protocols involving human subjects were insufficient to fully protect the latter’s well-being, Europe and the United States established a consensus that specified experimental procedures within the bounds of ethics and humanity. Powerful bodies and investigation teams have been created to review scientific procedures, and decide whether these procedures are acceptable or not. However, numerous disturbing questions still arise such as: How can one know what transpires between physician–investigators and patient-subjects? Should the responsibilities of research committees extend beyond the review of research protocols, to include the monitoring of consent conversations and the actual conduct of research with human subjects?
The author has suggested that the option of ethical justifiability as conditions of medical research involving human subjects. The conditions reflect a widely shared consensus in Europe and America. First is scientific adequacy. There must be respect for accepted scientific principles, knowledge of the natural history of the disease or problem under study, adequate preliminary laboratory and animal experimentation, and the proper scientific and medical qualifications of investigators. Second is protection of subjects. Patients come to doctors with expectations for care, relief and cure. This expectation must be met with fidelity to the end that performing an experiment which might be harmful to the client to any extent must never be done even though the result might be highly advantageous to science. It is very important that physicians and clinical investigators take pains to assure that patients really do understand what randomized, double-blinded clinical trials involve. They must bear primary responsibility for organizing consent conservations, and making certain that this mutually informing process really take place. Third is clinical equipoise or randomization. One group of physicians may favor one treatment and other group may favor another treatment but both groups recognize that there is real uncertainty and reasonable controversy about the relative merits of the treatments under study.
The Conclusion, Premises and Reasons
The author urges the readers to move beyond the ethics of vigilance and protection. Time is changing and the ethics of research with human beings has a history which demonstrates development throughout the centuries. The world today would not have potent and effective treatments for many diseases had it not been for earlier generations who participated as subjects in medical research. As time changes, a moral duty, although a strong term to use, is emerging and that duty is to participate in medical researches. Animal models are frequently lacking or inadequate and hinder complete development. Participation in medical research is now an intrinsic component of the responsibility we bear towards future generations, the generations of our children.